Associate Principal Scientist, Statistical Programming – Late-Stage Oncology

• Lead statistical programming activities for multiple and/or large, complex late-stage drug/vaccine clinical development projects
• Develop and execute statistical analysis and reporting deliverables, including safety and efficacy analysis datasets, tables, listings, and figures
• Support clinical trials, worldwide regulatory application submissions, and post-marketing activities
• Design and maintain statistical datasets supporting clinical development, outcomes research, and safety evaluation stakeholders
• Collaborate with statistics and project stakeholders to execute project plans efficiently and deliver high-quality work on time
• Serve as the statistical programming point of contact and knowledge holder throughout the product lifecycle
• Develop and validate analysis and report programming using global and therapeutic-area standards, departmental SOPs, and good programming practices
• Maintain and manage project plans, including resource forecasting
• Coordinate a global programming team, including outsourced provider staff
• Participate in departmental strategic initiative teams

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus a minimum of 9 years SAS programming experience in a clinical trial environment, OR MS in one of these fields plus a minimum of 7 years SAS programming experience in a clinical trial environment
• Effective interpersonal, negotiation, collaboration, written, oral, and presentation skills
• Experience developing analysis and reporting deliverables for R&D projects
• Experience leading large and/or complex projects and balancing competing priorities
• Significant expertise in SAS, including data steps, procedures, SAS/MACRO, and SAS/GRAPH
• Systems and database expertise
• Experience designing and developing complex programming algorithms
• Understanding of statistical terminology and concepts and ability to comprehend analysis plans
• Familiarity with clinical data management concepts
• Experience with CDISC and ADaM standards
• US and/or worldwide drug or vaccine regulatory application submission experience, including electronic submission deliverables
• Experience ensuring process compliance and deliverable quality
• Strategic thinking and ability to turn strategy into tactical activities
• Ability to anticipate stakeholder requirements
• Preferred: experience with GenAI tools such as Python, R, R Shiny, and Claude
• Preferred: working knowledge of reporting processes, SOPs, and SDLC
• Preferred: experience directing other programmers and mentoring
• Preferred: ability and interest to work across cultures and geographies
• Preferred: experience developing and managing project plans using Microsoft Project or similar
• Preferred: professional society involvement and process improvement experience

Demonstrates extensive expertise in SAS programming for clinical trials, including data steps, procedures, and compliance with CDISC and ADaM standards. Proven ability to lead complex projects, manage global programming teams, and deliver high-quality statistical analysis and reporting.

• SAS Programming Expertise
• Clinical Trial Experience
• Project Management Skills
• Statistical Analysis and Reporting
• Regulatory Submission Experience

• SAS Programming
• Statistical Analysis
• Data Management
• Programming Algorithms
• CDISC Standards
• ADaM Standards
• Statistical Terminology
• Resource Forecasting
• Project Planning
• Process Compliance

• Interpersonal Skills
• Collaboration
• Negotiation
• Presentation Skills
• Strategic Thinking

• Clinical Development
• Drug Development
• Vaccine Development
• Regulatory Applications
• Outcomes Research

• Microsoft Project
• GenAI Tools
• Python
• R
• R Shiny